Esomeprazole, Moxifloxacin and Amoxicilin for Rescue Therapy of Helicobacter Pylori Infection

Helicobacter Pylori Infection Clinical Trial

— ESAMOX  

Official title:

Randomized, Controlled, Multicenter Phase III Study for the Efficacy and Tolerability of Triple Therapy With Esomeprazole, Moxifloxacin and Amoxicillin for Rescue Therapy of Helicobacter Pylori Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00455806
• Other study ID #: ESAMOX_01_2007
• Secondary ID: EudraCT Numberr
• Status: Recruiting
• Phase: Phase 3
• First received: April 3, 2007
• Last updated: April 3, 2007
• Start date: January 2007
• Est. completion date: February 2008

Study information

• Verified date: March 2007
• Source: Technische Universität Dresden
• Contact: Stephan Miehlke, MD, PhD
• Phone: +493514585645
• Email: stephan.miehlk[@]uniklinikum-dresden.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Successful H. pylori eradication therapy remains a challenge in medical practice. Despite promising data for first-line, second-line and rescue treatment options based on clinical trials as well as guidelines and expert recommendations, success rates can often not be reproduced in general practice. Rescue options for patients with failed initial or second-line therapy are definitely needed. The new fluoroquinolone moxifloxacin may represent an effective and save treatment option (in combination with a PPI and amoxicillin) for rescue therapy of H- pylori positive patients.However, optimal duration of therapy (7-day course vs 14-day course) has to be determined

Description:

Successful H. pylori eradication therapy remains a challenge in medical practice. Currently, a PPI - based triple therapy containing clarithromycin, amoxicillin or nitroimidazole given for 7 days is the recommended first line treatment approach with an expected eradication success rate of approximately 80%. As second-line treatment option in case of failure, a RBC-based quadruple therapy is currently recommended curing another 80% of patients, leaving a subset of patients with persistent H. pylori infection. Resistance to fluoroquinolones is low in most countries,hence these compounds are potential candidates for second-line and rescue treatment. The new fluoroquinolone moxifloxacin launched by Bayer in 1999 for the treatment of respiratory tract infections, has a broad antibacterial spectrum comparable to levofloxacin but fewer phototoxic and central nervous system excitatory effects. The possible role of moxifloxacin in H. pylori eradication is since under clinical investigation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• male/female, age >/=18 years

• Helicobacter pylori infection proven by histology and culture

• indication for eradication therapy according to the Maastricht-III

• at least one failed prior eradication attempt

• pretherapeutic resistance testing (culture)

• written informed consent

Exclusion Criteria:

• in vitro resistance to moxifloxacin or amoxicillin

• current complicated peptic ulcer disease

• daily intake of NSAIDs

• co-medication with drugs known to interact with the study medication

• history of gastric surgery/vagotomy

• medical treatment for depression, known suicide attempt

• severe cardiological diseases such as bradyarrythmia, QT changes

• malignant disease

• gravidity, nursing

• women with child bearing potential must perform contraceptive measures

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Gastritis
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

Drug:
• esomeprazole

• moxifloxacin

• amoxicillin

Locations

Country	Name	City	State
Germany	Gastroenterologist, private praxis	Cologne
Germany	Med. Dept. I, Gastroenterology, University Hospital, Technical University of Dresden	Dresden
Germany	Gastroenterologist / private praxis	Görlitz
Germany	Medical Department, University Homburg/Saar	Homburg/Saar
Germany	Medical Dept. I, University Hpspital Kiel	Kiel
Germany	Gastroenterologist / private praxis	Munich
Germany	Technical University of Munich, Medical Dept. II	Munich
Germany	Gastroenterologist / private praxis	Oldenburg
Germany	Med. Department, Jung-Stilling Krankenhaus	Siegen

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

References & Publications (8)

Cheon JH, Kim N, Lee DH, Kim JM, Kim JS, Jung HC, Song IS. Efficacy of moxifloxacin-based triple therapy as second-line treatment for Helicobacter pylori infection. Helicobacter. 2006 Feb;11(1):46-51. — View Citation

Di Caro S, Ojetti V, Zocco MA, Cremonini F, Bartolozzi F, Candelli M, Lupascu A, Nista EC, Cammarota G, Gasbarrini A. Mono, dual and triple moxifloxacin-based therapies for Helicobacter pylori eradication. Aliment Pharmacol Ther. 2002 Mar;16(3):527-32. — View Citation

Mégraud F, Lamouliatte H. Review article: the treatment of refractory Helicobacter pylori infection. Aliment Pharmacol Ther. 2003 Jun 1;17(11):1333-43. Review. — View Citation

Miehlke S, Bayerdörffer E, Graham DY. Treatment of Helicobacter pylori infection. Semin Gastrointest Dis. 2001 Jul;12(3):167-79. Review. — View Citation

Miehlke S, Hansky K, Schneider-Brachert W, Kirsch C, Morgner A, Madisch A, Kuhlisch E, Bästlein E, Jacobs E, Bayerdörffer E, Lehn N, Stolte M. Randomized trial of rifabutin-based triple therapy and high-dose dual therapy for rescue treatment of Helicobacter pylori resistant to both metronidazole and clarithromycin. Aliment Pharmacol Ther. 2006 Jul 15;24(2):395-403. — View Citation

Miehlke S, Schneider-Brachert W, Bästlein E, Ebert S, Kirsch C, Haferland C, Buchner M, Neumeyer M, Vieth M, Stolte M, Lehn N, Bayerdörffer E. Esomeprazole-based one-week triple therapy with clarithromycin and metronidazole is effective in eradicating Helicobacter pylori in the absence of antimicrobial resistance. Aliment Pharmacol Ther. 2003 Oct 15;18(8):799-804. — View Citation

Morgner A, Labenz J, Miehlke S. Effective regimens for the treatment of Helicobacter pylori infection. Expert Opin Investig Drugs. 2006 Sep;15(9):995-1016. Review. — View Citation

Nista EC, Candelli M, Zocco MA, Cazzato IA, Cremonini F, Ojetti V, Santoro M, Finizio R, Pignataro G, Cammarota G, Gasbarrini G, Gasbarrini A. Moxifloxacin-based strategies for first-line treatment of Helicobacter pylori infection. Aliment Pharmacol Ther. 2005 May 15;21(10):1241-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of a combination of esomeprazole (E), moxifloxacin (M) and amoxicillin (A) for third line therapy of H. pylori infection.
Primary	Comparison of EMA 7 days versus EMA 14 days. Hypothesis: superiority of EMA 14 days 4 weeks after end of eradication therapy
Secondary	Tolerability,safety, post treatment resistance, influence of host genetics (CYP status) and pathogenicity factors of H. pylori on treatment success.